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The purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
| |
| Part 3 | Experimental |
| |
| Part 1a | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KarXT | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1/1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT | Up to approximately day 24 | |
| Part 1/1a: GMR of Area under the plasma concentration-time curve (AUC) of midazolam with and without KarXT | Up to approximately day 24 | |
| Part 2: GMR of Cmax of fexofenadine with and without KarXT | Up to approximately day 24 | |
| Part 2: GMR of AUC of fexofenadine with and without KarXT | Up to approximately day 24 | |
| Part 3: GMR of Cmax of digoxin with and without KarXT | Up to approximately day 24 | |
| Part 3: GMR of AUC of digoxin with and without KarXT | Up to approximately day 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to approximately day 47 | |
| Number of participants with serious adverse events (SAEs) | Up to approximately day 47 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON - Lenexa | Recruiting | Lenexa | Kansas | 66219-9746 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| ID | Term |
|---|---|
| C075257 | xanomeline |
| C003330 | trospium chloride |
| D008874 | Midazolam |
| C093230 | fexofenadine |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam | Drug | Specified dose on specified days |
|
| Fexofenadine | Drug | Specified dose on specified days |
|
| Digoxin | Drug | Specified dose on specified days |
|
| Number of participants with physical examination abnormalities |
| Up to approximately day 24 |
| Number of participants with vital sign abnormalities | Up to approximately day 24 |
| Number of participants with 12-lead electrocardiogram abnormalities (ECGs) | Up to approximately day 24 |
| Number of participants with clinical laboratory assessment abnormalities | Up to approximately day 24 |
| Number of participants with suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to approximately day 24 |
| Number of participants with adverse event of special interest (AESIs) | Up to approximately day 47 |
| D006571 | Heterocyclic Compounds |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |